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Breast CancerPhase 2ZEMYNCT03558490

A Study to Assess the Feasibility of an E-Health System (ZEMY) Designed to Manage Symptoms in Participants With Breast Cancer Under Anti-Cancer Treatment

A Phase 2 study testing ZEMY software and Investigator's choice of anti-cancer treatment (except immunotherapy) in people with Breast Cancer, run by Hoffmann-La Roche at 5 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a three-month open-label, multicenter, interventional, single arm study located in France, designed to assess feasibility and reliability of the e-Health ZEMY software medical device under investigation for use by participants with breast cancer, who are starting an anti-cancer treatment at any stage of the… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
ZEMY software and Investigator's choice of anti-cancer treatment (except immunotherapy)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
5 sitesFrance
Study dates
12 Jun 2018to 19 Apr 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female patients with breast cancer starting a treatment including oral and/or parenteral anti-cancer drugs (chemotherapy and/or targeted therapies, hormonotherapy)
  • Inter-cycle duration between hospital visits ≥14 days (this period of time is estimated to be consistent with a need for support during the home setting period)
  • Patients shall be prescribed loperamide or any other anti-diarrheic treatment in case of diarrhea and prescription for any medication indicated in case of nausea/vomiting
  • Able to speak and read French and to use a smartphone embedding ZEMY, in the investigator's judgment
  • Able to comply with the study protocol, in the investigator's judgment
  • Patient affiliated to the national social security or beneficiary to such insurance.

Who cannot join

  • Pregnant
  • Already enrolled in a clinical study involving experimental medication or eHealth device
  • Concomitant malignancy
  • ECOG score >2
  • Treated with single hormonotherapy, single surgery or single radiotherapy, immunotherapy.
  • Patient whose mental state renders her unable to understand the nature, purposes, and consequences of the study
Show all 9Show fewer
  • Patient not trained to the use of ZEMY
  • Patient not trained to take her blood pressure measurement
  • Patient deprived of her liberty by judicial or administrative order.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

France5 sites

  • Centre Francois Baclesse; Oncologie

    Caen, 14076

  • Centre Jean Perrin; Oncologie

    Clermont-Ferrand, 63011

  • Hopital Prive Jean Mermoz; Cancerologie

    Lyon, 69373

  • Hopital Saint Louis; Oncologie Medicale

    Paris, 75475

  • Institut du Cancer Coulancy Reims

    Reims, 51100

Other trials in France

About this study

Official title: Feasibility Assessment of an E-Health System (ZEMY) Designed to Manage Symptoms in Patients With Breast Cancer Under Anti-Cancer Treatment

This is a three-month open-label, multicenter, interventional, single arm study located in France, designed to assess feasibility and reliability of the e-Health ZEMY software medical device under investigation for use by participants with breast cancer, who are starting an anti-cancer treatment at any stage of the disease, to manage disease symptoms and anti-cancer treatment-related toxicities while at home.

Conditions
Breast Cancer
Being tested
ZEMY software, Investigator's choice of anti-cancer treatment (except immunotherapy)
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZEMY softwareDevice

    The ZEMY software medical device integrates specific algorithms based on international and validated guidelines. It provides individually customized information and defines for the patient an adapted action to follow for each of the following reported symptoms or anti-cancer treatment-related toxicities: diarrhea, fatigue, nausea, vomiting, cutaneous and mucosal toxicities, pain, fever/febrile neutropenia, high blood pressure, anxiety and depression.

    During the 3-month study period, participants will be asked to enter their symptoms among the 10 symptoms listed in ZEMY on their smartphone dedicated to the study. Consequently, ZEMY software will provide to the participants adapted real-time information to advise them on the management of the experienced symptom and recommend hygienic-dietetic advice and symptomatic treatments.

  • Investigator's choice of anti-cancer treatment (except immunotherapy)Drug

    All anti-cancer treatments (except immunotherapy) will be left to the free choice of investigators. Participants shall be prescribed by the healthcare team both of the following symptomatic treatments: loperamide or any other anti-diarrheic treatment in case of diarrhea; and a prescription for any medication indicated in case of nausea/vomiting. A written prescription will be made by the investigator at screening for loperamide or any other anti-diarrheic treatment and symptomatic treatment for nausea/vomiting with documented dosage and duration.

Study groups in NCT03558490
Study groupRoleWhat they receive
ZEMY softwareExperimentalNot described
Receives: Device: ZEMY software; Drug: Investigator's choice of anti-cancer treatment (except immunotherapy)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Who Successfully Use ZEMY

    A participant will be considered as successful in terms of the feasibility of using ZEMY if she has completed at least three symptom reported connections and if the rate of completed symptom reported connections for this participant is ≥ 60%.

    Measured: 3 months

Secondary outcomes (15)

  1. Percentage of Appropriate Automatic Messages and Recommendations for Each Symptom by ZEMY, as Evaluated by the Investigator at Each Visit

    Measured: At Weeks 3, 6, 9, and 12 (Up to 3 months)

  2. System Usability Scale Score, Rated by Participants and Healthcare Professionals (HCPs)

    Measured: At 3 months

  3. Satisfaction with ZEMY, Assessed on a Visual Analog Scale by Participants and HCPs

    Measured: At 3 months

  4. Percentage of Participant Answered Entries per ZEMY Requests for Solicited Symptom Information

    Measured: 3 months

  5. Number of Automatic Messages Generated by ZEMY per Participant Over the Study Period

    Measured: 3 months

  6. Number of Automatic Messages Generated by ZEMY per Symptom Over the Study Period

    Measured: 3 months

  7. Number of Recommendations Generated by ZEMY per Participant Over the Study Period

    Measured: 3 months

  8. Number of Recommendations Generated by ZEMY per Symptom Over the Study Period

    Measured: 3 months

  9. Number and Type of Device Deficiencies

    Inadequacy of an investigational medical device related to its identity, quality, durability, reliability, safety or performance. This may include malfunctions, use error, or inadequacy in the information supplied by the manufacturer.

    Measured: 3 months

  10. Number and Type of Adverse Device Effects

    Adverse event related to the use of an investigational medical device.

    Measured: 3 months

  11. Number and Type of Serious Adverse Device Effects

    Adverse device effect that has resulted in any of the consequences characteristic of a serious adverse event.

    Measured: 3 months

  12. Number and Type of Unanticipated Serious Adverse Device Effects

    Serious adverse device effect which by its nature, incidence, severity or outcome has not been identified in the current version of the risk analysis report.

    Measured: 3 months

  13. Change From Baseline in the EuroQoL 5-Dimension (EQ-5D-5L) Health Questionnaire Score at Each Study Visit

    Measured: At Baseline and Weeks 3, 6, 9, and 12 (Up to 3 months)

  14. Change From Baseline in the European Organization for Research and Treatment of Cancer's Quality-of-Life Questionnaire (EORTC QLQ-30) Score at Each Study Visit

    Measured: At Baseline and Weeks 3, 6, 9, and 12 (Up to 3 months)

  15. Change From Baseline in the European Organization for Research and Treatment of Cancer's Breast Cancer-Specific Quality-of-Life Questionnaire (EORTC QLQ-BR23) Score at Each Study Visit

    Measured: At Baseline and Weeks 3, 6, 9, and 12 (Up to 3 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2018
  2. Study start12 Jun 2018
  3. Primary completion19 Apr 2019
  4. Study completion19 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03558490
Sponsor's protocol ID
ML39208
Acronym
ZEMY
Status last verified
Jul 2019
First submitted
4 Jun 2018
Last updated
22 Jul 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ZEMY software and Investigator's choice of anti-cancer treatment (except immunotherapy) in people with Breast Cancer, run by Hoffmann-La Roche at 5 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Successfully Use ZEMY (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03558490.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2019.

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